"Community-based, eHealth Supported Management of Cardiovascular Risk Factors by Lay Village Health Workers (ComBaCaL aHT TwiC 1 & ComBaCaL aHT TwiC 2)

Summary

ComBaCaL aHT TwiC 1 and aHT TwiC 2 are two cluster-randomized controlled trials that are identical in intervention, design and endpoints. TwiC 1 enrols individuals with uncomplicated aHT with baseline BP values above treatment targets and the hypothesis is that in intervention clusters where community-based treatment is offered, a higher proportion will have controlled aHT at twelve months' follow-up as compared to control clusters where participants are referred to the facility for further care after diagnosis. TwiC 2 enrols individuals with uncomplicated pharmacologically controlled aHT with the hypothesis that the offer of community-based antihypertensive treatment is non-inferior to facility-based care with regard to BP control rates at twelve months. The trials are nested within the ComBaCaL (Community-Based Chronic disease care Lesotho) cohort study (EKNZ ID 2022-00058, clinicaltrials.gov ID NCT05596773), a platform for the investigation of chronic diseases and their management in rural Lesotho that is maintained by local chronic care village health workers (CC-VHWs). 50% of the villages being part of the overarching ComBaCaL cohort will be randomly allocated to receive the TwiC intervention. The non-selected villages will serve as comparators and follow the regular ComBaCaL cohort activities conducted by CC-VHWs, including screening, diagnosis, standardized counselling and referral to a health facility for further therapeutic management. The TwiC intervention will be offered to all eligible people living with aHT in the sampled intervention villages. Individuals with uncomplicated uncontrolled and uncomplicated controlled aHT at baseline will be enrolled in aHT TwiC 1 and aHT 2 respectively. In case of complicated disease, unclear diagnosis, or presence of clinical alarm signs or symptoms, participants will be referred to the closest health facility for further investigation.

Timeline

Start

2023-09-09

Primary completion

2025-05-04

Completion

2027-12-31

Publications

• Background Gerber F, Gupta R, Lejone TI, Tahirsylaj T, Lee T, Sanchez-Samaniego G, Kohler M, Haldemann MI, Raeber F, Chitja M, Mathulise M, Kabi T, Mokaeane M, Maphenchane M, Molulela M, Khomolishoele M, Mota M, Masike S, Bane M, Sematle MP, Makabateng R, Mphunyane M, Phaaroe S, Basler DB, Kindler K, Burkard T, Briel M, Chammartin F, Labhardt ND, Amstutz A. Community-based management of arterial hypertension and cardiovascular risk factors by lay village health workers for people with controlled and uncontrolled blood pressure in rural Lesotho: joint protocol for two cluster-randomized trials within the ComBaCaL cohort study (ComBaCaL aHT Twic 1 and ComBaCaL aHT TwiC 2). Trials. 2024 Jun 6;25(1):365. doi: 10.1186/s13063-024-08226-2.
• Gerber F, Sanchez-Samaniego G, Gupta R, Lejone TI, Tahirsylaj T, Raeber F, Chitja M, Mathulise M, Kabi T, Mokaeane M, Maphenchane M, Molulela M, Khomolishoele M, Mota M, Masike S, Bane M, Mofokeng M, Sematle MP, Makabateng R, Mphunyane M, Sao L, Tlahali M, Litaba M, Basler DB, Kindler K, Ayakaka I, Grimm P, Burkard T, Chammartin F, Amstutz A, Labhardt ND. Lay community health worker-led care with mobile decision support for uncontrolled hypertension: a cluster-randomized trial. Nat Med. 2026 Mar;32(3):915-923. doi: 10.1038/s41591-026-04208-w. Epub 2026 Feb 12.

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